1. Field of the Invention
The present invention relates to a method and an apparatus for in situ destruction of the inner lining of body organs, and more particularly the providing of a selective destruction of the endometrium with selective use of a bipolar/monopolar application of RF energy as an alternative to hysterectomy for treatment of uterine bleeding. It also relates to a method of manufacturing such an apparatus.
2. Discussion of Background
Prior techniques for removing or destroying the inner lining of body organs have been explored in order to provide for an alternative to surgical removal of the body organs for treatment of diseases and other abnormal conditions. Prior techniques involved the destructive treatment of the inner linings with chemicals and with various forms of thermal energy such as radio frequency, microwave heating, cryotherapy, laser surgery and electrosurgery. Radio frequency and microwave energies have also been applied directly to the linings to generate heat in situ.
One type of thermal destruction is described in U.S. Pat. No. 4,979,949 wherein thermal ablation of the mucosal layer of a gall bladder is accomplished by resistive heating with an RF balloon electrode. Electric current is delivered from an electrode in the center of the balloon by a conductive expansion liquid filling the balloon. This device has power loss which occurs in the conductive fluid, and it cannot be adapted for anything but a single electrode arrangement.
In another example of prior art treatment, balloon catheters have been supplied with a heated fluid for thermal ablation of hollow body organs as described in U.S. Pat. No. 5,045,056. Furthermore, application of microwave and high frequency RF energy to body areas to destroy body tissue, using single electrodes enclosed in expanded balloons have been described in U.S. Pat. No. 4,662,383 and U.S. Pat. No. 4,676,258.
The disadvantage of the procedures occurring in the prior art such as described above include a lack of uniform large area treatment because these procedures involve a lack of uniform control or temperature sensing ability to ensure complete ablation.
Other procedures developed to date involve manual applications of small treatment tools to successive areas of the lining which is an expensive operating room procedure and which, similar to the other previous heat balloon treatments, involve limited assurance of uniform results.